A Study on the Performance of Metal and Plastic Connectors in Injector and Micro- Catheter Connection in Vascular Intervention

 

Joongseok Go¹*, Joonkoo Choi², Ghajung Kim³

¹Dept. of Radiology, Seoul National University Bundang Hospital, 82, Gumi-ro173beon-gil,

Bundang-gu, Seongnam-si, Gyeonggi-do, 13620 korea

²Department of  Radiological Science, Graduate School of Health Science, Far East University, 76-32, Daehak-gil, Gamgok-myeon, Eumsung-gun, Chungcheongbuk-do, 27601, Korea

³Department of  Radiological Science, Graduate School of Health Science, Far East University, 76-32, Daehak-gil, Gamgok-myeon, Eumsung-gun, Chungcheongbuk-do, 27601, Korea

 

ABSTRACT:

Background/Objectives: Contrast agents are used in interventional procedures for vascular treatment. A connector is required to connect the catheter in your body. I want to find the right connection tube.

Methods/Statistical analysis: The performance evaluation items of the connecting tube that need to be connected with the micro catheter during angiography are the connection ability, pressure ability, non-moving ability and psi change during fixation I divided it. In order to minimize the error due to the measurement error, 10 measurements were made and the mean value was calculated and evaluated by 3 radiologists in the same way.

Findings: It is the most suitable disposable syringe connector when the connection part of a product made of plastic material is correctly fixed to various treatment tools when used in clinic of each hospital. However, there are users who worry about the infection during the fixed process and avoid it because of the hassle.So far, the health authorities' prescriptions for injectors or injectors combined with metal and plastic connections have not been explicitly provided, but the reuse of disposable disinfectants will turn into taboos for each other. Therefore, if the connection is used at each hospital, the connection area of ​​the product made of plastic is composed of various surgical tools such as towel clips or mosquitoes. However, there is concern that there may be concerns about the possibility of infection and annoyance. As a result, it is best to lock the connection of the plastic injector connector and use it when considering the cost of infection and cost evaluation, as well as the cost of infection.

Improvements/Applications: Is better or equal to the metal tube of the evaluation area.In terms of cost, it is best to use a plastic connector after fixing the connector luer.

 

 

 

 

1.      INTRODUCTION:

Recently, in the intervention room, the use of disposable products to prevent infections is becoming an issue when treating patients with vascular diseases.¹The National Anti-Corruption and Civil Rights Commission (NHRC)recommended establishing standards for disposable medical devices and prohibiting reuse, and currently, legislation is in progress in the National Assembly.²So, the connecting tube connected to the injector must use disposable products.The mainly used connecting tubes made of metal are expensive to use because the product is not covered by medical insurance.^{3, 4}  So some hospitals use metal products and some hospitals use plastic products.

 

Recently, as a result of the development of micro-catheter, which is more advanced than the existing product, an intervention procedure for micro blood vessels is possible,and due to the high pressure applied to the connecting tube, the hardness of the product is important. The connector's main points are the tonnage capacity to withstand the high pressure, the sealing capacity to connect without catheter leakage, the non-moving ability to keep the catheter and connecting parts from moving even under strong pressure. The purpose of this study is to investigate a suitable Disposable Injector connecting tube by comparing the plastic connecting tube which is relatively inexpensive and the metal connecting tube among the injector connecting tubes used in Korea.⁵

 

2. MATERIALS AND METHODS:

2.1. Material and Equipment:

2.1.1. Injector connecting tube:

The selected products must have a solid mesh inside to withstand the rated Pressure 1200 PSI.In order to carry out the experiment according to the difference of the material of the connecting part, two kinds of products were selected, one made of plastic and the other made of metal.Among them, plastic products were chosen to consider price competitiveness rather than metal products.⁶(Table 1, Figure 1)

 

Table 1: Specification of injector connecting tube used in the experiment

Product name	Rated Pressure	Connector	Manufacturer	OD	ID	Length
				(mm)	(mm)	(mm)
Connecting Tube	1200	Metal	Cook Medical, Daniels way Bloomington ,US	2.93	1.7	2400
KM	1200	Plastic	KM C&R, Korea	3.65	1.8	2300
Pressure LINE
High pressure Braided tube	1200	Plastic	Enove International Group Co. LTd
			Jiangsu Province China	3.65	1.8	2500

 

 

(a)                                 (b)                         (c)

Figure 1, (a) COOK (b) KM C&R(c) Enove

 

2.1.2. Experimental models and materials:

The model was made with vascular phantom and liquid set line to make the condition similar to the blood vessel as much as possible. The normal saline at 37 ℃ similar to the human body temperature was kept flushing with the pressure bag at 120mmHg. And 5Fr sheath was inserted, fixed with Tegaderm and tested with RH catheter and 2.0Fr Micro catheter. (Figure 2)

·        Auto injector: LF(Liebelflarsheim) Angiomatillumena version 9.06

·        •Vascular Phantom (Elastrat,Geneva, Switzerland)

·        Micro catheter: 2.0Fr Progreat (Terumo, Tokyo, Japan) –maximum flow 1.5ml/sec.

·        Contrast:Visipaque 270mg I/ML (GE Healthcare Ireland, Cork, Ireland)

·        Sheath: 5Fr Radiofocus (Terumo, Tokyo, Japan)

·        Catheter: RH 5Fr 75cm (Cook Medical, Daniels way Bloomington,US)

·        Pressure Bag (Medex medical, Kyungkido, Korea)

·        Infusion set (Sbdad, Seoul, Korea)

·        Normal saline

 

Figure 2 (a) Experimental model (b) Vascular phantom (c) Pressure bag

 

2.2. Experimental conditions:

1.      In order to check the damage status of the micro catheter hub among the evaluation items of the connecting ability of the injector connecting tube, the connection part was separated and recombined after each measurement.

2.      Micro catheter was flushed with saline before each measurement to reduce the error of the measurement result due to the stickness the contrast medium.

3.      In order to reduce the mechanical overload error of the auto injector, we gave enough interval time after each experiment.

 

2.3. Experimental method:

The test items were classified into Connection ability, Pressure ability, Non-moving ability and PSI (PSI change during fixation) by referring to manufacturing priority items of the injector connecting tube manufacturer. ⁷(Table2).

 

Table 2:Evaluation Items

Connection ability	There should be no leaks when connecting the micro-catheter to the connection and should not cause catheter connection deformation.
Pressure ability	It should be possible to inject up to the limit value of the micro-catheter and the appropriate Achieved PSI for each flow should be measured.
Non-moving ability	Do not cause dislocation of the micro-catheter tip due to the movement of the connectors.
(PSI change during fixation)	There should be no change in the PSI even if the connection is arbitrarily fixed.

 

The flow limit of the micro- catheter used in this experiment was 1.5 ml / sec, but the flow rate was divided into three groups of 1, 1.5, and 1.8 ml / s for various experiments.⁸The amount of contrast media was experimented at 6, 8, 10, 12, 14, and 16 sec for each flow rate (ml / sec). ⁸However, in the 1.8ml/sec, when the contrast injection time was maintained for more than 10 seconds, the pressure exceeded the maximum PSI (1200 PSI) and the experiment was performed for up to 10 seconds.⁹

 

2.3.1. Connection ability experimental:

The leakage of the connection was visually confirmed during the experiment with different conditions, and when there was leakage, the amount was measured using a syringe. (Figure 3)

 

Figurer 3. Leakage measurement method

 

2.3.2. Pressure ability experimental:

The Achieved Pressure on the Auto Injector according to the flow rate was recorded and verified by confirming that injection was possible up to 1.5 ml / sec, which is the limit value of the micro catheter used in the experiment.

 

2.3.3. Non-moving ability experimental:

In order to objectively evaluate the movement of the connections, we used a scale bar to set the score according to the movement and to record the movement score. To objectively evaluate the movement of the joints, use the scale bar to move and the score of motion was recorded. (Table 3, Figure 4)

 

Table 3:Left and right up and down movement score table

Left and right up and down movement	score
Same or less than 1cm	1
Same or less than 1 to 2 cm	2
more than 3cm	3

 

Figure 4. Fixed capacity evaluation method

 

2.3.4. PSI change during fixation experimental:

In order to investigate the change of Achieved pressure depending on whether the connection is fixed or not, tegaderm was used to test for the same conditions by dividing the connections into fixed and unfixed.^{10, 11, 12} (Figure 5.)

 

(a)                                                    (b)

Figure 5. (a) not fixed(b) fixed

 

2.4. Data analysis and statistical processing:

Reliability analysis and one-way ANOVA ofIBM SPSS statistics v18.0 (Ontario, Canada) were used for the statistical significance of the experiments.

 

3. RESULTS AND DISCUSSION:

3.1. Experimental conditions

3.1.1. Connection abilityExperiment result:

The average leakage value of the three injector connecting tubes is as follows.

1.      There was no contrast leakage in the connecting tube of the plastic connecting part, but in the case of the connecting tube with metal connection, the contrast media leakage started after 12 seconds at 1.0 ml / sec.Also, as the flow rate increased and sec became longer, more leakage occurred and leakage of 0.8ml ~ 3ml was observed depending on the condition. (Table 4)

2.      When tightly fixed, plastic connections made of the same material as the connections of the micro-catheter have a slight deformation was caused to each other, and a completely sealed state was maintained. However, a connecting tube made of metal is not deformed even when it is fixed with a strong force, so that it is difficult to complete sealing and leakage occurs.Also, as the rejoining was repeated, the metal connection caused damage to the micro- catheter connection, resulting in more contrast leakage.(Figure 6)

 

Table 4: Connection ability experiment result

Leakage (ml)
Flow rate (ml/sec)	sec (ml)	COOK	Enove	KM C&R
1.0ml/sec	6 sec   (6ml)	None	None	None
	8 sec   (8ml)	None	None	None
	10 sec  (10ml)	None	None	None
	12 sec  (12ml)	0.9 ml	None	None
	14 sec  (14ml)	1.0 ml	None	None
	16 sec  (16ml)	1.0 ml	None	None
1.5ml/sec	6 sec   (9ml)	1.3 ml	None	None
	8 sec   (12ml)	1.4 ml	None	None
	10 sec  (15ml)	1.5 ml	None	None
	12 sec  (18ml)	1.6 ml	None	None
	14 sec  (21ml)	1.8 ml	None	None
	16 sec  (24ml)	1.8 ml	None	None
1.8ml/sec	6 sec   (11ml)	2 ml	None	None
	8 sec  (14ml)	2.5 ml	None	None
	10 sec  (18ml)	3 ml	None	None

 

(a)                                                                         (b)

Figure 6. (a) contrast leakage (b) broken or not broken

 

3.1.2.Pressure ability Experiment result

The average value of achieved PSI for each connecting tube condition is as follows.

 

Insert Figure 7

 

Figure 7. Mean value of Achieved PSI by connecting tube condition

 

During the experiment, none of the three products showed any external damage (breakage, cracks, deformation), and injection was possible up to 1.5 ml/sec.The PSI difference between products was statistically insignificant as p = 0.727, indicating that there was no difference in performance between the three products.

 

All three products showed an increase in PSI with increasing flow rate (ml/sec) and time (sec), a steady increase with increasing time, and a gradual increase with PSI from more than 10 seconds.However, it was difficult to measure the PSI accurately from the time when the connection part started to leak, and the achieved PSI was lower than other products. (Figure 7 Circle part)

 

3.1.3. Non-moving ability Experiment result:

The fixing ability score of the three connecting tubes was statistically significant (p = 0.01). The results were as follows.(Figure 8)

Figure 8. Non-moving ability evaluation result

 

The metal connection tube was less moving than the plastic connection tube due to the heavy connection.

The metal connecting tube started the movement corresponding to one point of evaluation at the 8 second point of the flow rate of 1.5 ml / sec, the plastic connecting tube started to move to 1 point at the 6 second injection time of 1.0 ml / sec.All three products increased in motion with increasing flowrate.

 

3.1.4. PSI change during fixation Experiment result

When compensating the fixing capacity of three products, the difference in the value of the PSI was statistically significant.( p=0.028) and the result is as follows.(Figure 9)

 

 

Figure 9 PSI results when supplementing fixed capacity

When the connector was fixed, PSI increased by 10 to 50. This suggests that if the micro-catheter and the connecting tube are not moved, the connection between the injector and the connecting tube is relatively pressurized and the PSI is increased.Experimental data were obtained using injector connecting tubesfor each product and five micro-catheters, and the average of five experiments was recorded. For objective evaluation, three radiologist technician assessed it in the same terms and conditions.

 

3.2. DISCUSSION:

Injector connecting tube performance evaluation criteria were divided into four categories, and the products made of plastic and metal connectors were compared and tested to see which disposable injector connecting tubes were suitable.^{13, 14} In the connection ability, contrast leakage occurred in the product made of metal connector, there was no difference in performance between the three companies in the pressure ability evaluation(P=0.727). In the non-moving ability, the products made of plastic connectorwere more to move due to the weight difference with the metal joint products. This means that the probability of moving of the micro catheter tips is increased when only the connecting tube is changed in the same procedure environment.¹⁵

 

However, in the PSI change during fixation experiment, the pressure increased by 10 ~ 50 PSI when the connection was fixed. This may not be a major factor in various clinical variables in clinical practice. The limitation of this study is that it does not apply to actual patients because it is a value except for the parameters such as vascular structure, thickness, blood pressure, and blood flow in various patients. Also in this study, tegadem is used to fix the coupling tube connection, but it is sometimes difficult to fix it using tegadem during actual procedures.^{16, 17} And we did not get results using various instruments such as wet gauze, mosquito, forceps, etc.Finally, since all micro-catheters have not been studied, further studies on various treatment materials will be needed. Also, it is necessary to obtain a sample number that can satisfy the statistical significance and to obtain more objective result.

 

4.      CONCLUSION:

Until now, the regulations or recommendations of injector connect tubes made of metal and plastic connections were not clearly provided by sanitation authority. However, reuse of disposable medical devices will be strictly prohibited.So, it is considered to be the most suitable Disposable Injector connector if the connecting part of the product made of plastic material is properly fixed with various treatment tools such as Towel Clip or Mosquito. However, there is an infection worry in the process of fixation, and there is an operator who avoids it because of troublesome.Therefore, it would be best suited to lock and use the plastic injector connecting tube when considering the infection problem, cost and performance assessment.

 

5. REFERENCES:

1.       A Study on the Reuse Principles of Diagnostic and Therapeutic Materials, Research Report of Korea Health and Medical Research Institute 2009, 1-321 (321),

2.       People's Rights Committee2009,| Vol. 06 48P

3.       ShiroMiyayama, Masashi Yamashiro, Masaya Ikuno:  Ultraselectivetranscatheter arterial chemoembolization for small hepatocellular carcinoma guided by automated tumor-feeders detection software: technical success and short-term tumor response,SpringerScience+Business Media New York 2014 A Published online.

4.       Antonio Facciorusso, Raffaele Licinio, Nicola MuscatielloTransarterial chemoembolization: Evidences from the literature and applications in hepatocellular carcinoma patients World J Hepatol. 2015, Aug 8; 7(16):

5.       Eamonn Hobbs, Irvin F. Hawkins, Arthur L. Zimmet, John GoodmanContrast media injector  E-Z-Em, Inc. US 07/629,180

6.       Duckwiler G et al. Intravascular microcatheter pressure monitoring: experimental results and early clinical evaluation.

7.       Marc Mehrzad Jalisi, Mark Richardson, David M. AndersonGuidewire having braided wire over drawn tube construction Advanced Cardiovascular Systems, Inc.

8.       Korea Institute of Machinery and Materials Reliability Technology Committee: Hydraulic hose assembly for construction machine, 2014, RS-KIMM,

9.       Measurement and Comparative Evaluation of the Limit Flow Rate of Micro Catheter (Korean Society of Intervention Technology)2014, 17 (1) 114-119,

10.     J Fitzgerald, H Andrew, B ConwayOutpatient angiography: a prospective study of 3 French catheters in unselected patients. Department of Clinical Radiology, Manchester Royal Infirmary, UK.

11.     Teiyu Yamauchi et al. Optimum iodine concentration of contrast material through microcatheters: hydrocynamic analysis of experimental results.Phys. Med. Biol.2002, 47

12.     A study on the relationship between flow rate and pressure (PSI) of a microcatheter. Catheter (Korean Society of Intervention Technology)), 2010, 13 (1) 83-91 (9)

13.     Hailey D, Jacobs PD, Ries NM, Polisena J. Reuse of single use medical devices in Canada: clinical and economic outcomes, legal and ethical issues, and current hospital practice. Int J Technol Assess HealthCare. 2008 Fall; 24(4):430-6.

14.     CADTH, Reprocessing of single-use medical devices: clinical, economicand health services impact. 2008

15.     Rufenacht D, Merland JJ. A new and original microcatheter system for hyperselective catheterization and endovascular treatment without risk ofarterial rupture. J Neuroradiol 1986; 13: 44 –54.

16.     T. Gulbrandsen: Chemistry of X-ray Contrast Media, Contrast Media in Practice, Springer Verlag, 1993, 6-11,

17.     Yamauchi T, Furui S, Harasawa A, Ishimura M, Imai T, Hayashi T. Optimum iodine concentration ofcontrast material through microcatheters: hydrodynamic analysis ofexperimentalresults. Phys Med Biol 2002; 47:2511– 2523.

 

 

Accepted on 24.02.2018        © RJPT All right reserved

Research J. Pharm. and Tech 2018; 11(2): 575-580.